CLASS II Drug recall · Reported 7 Feb 2024 · FDA Enforcement Report
Budesonide Extended-Release Tablets, 9 mg recalled
Golden State Medical Supply is recalling Budesonide Extended-Release Tablets, 9 mg, distributed in Illinois. The recall was initiated on 12 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0276-2024
- FDA event ID
- 93827
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2024
- FDA classified
- 29 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 12 Jan 2024 | Recall initiated by company | |
| 29 Jan 2024 | Classified by FDA | +17 days |
| 7 Feb 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Where it was distributed
Illinois only
Questions about this recall
Is Budesonide Extended-Release Tablets, 9 mg recalled?
Yes. Golden State Medical Supply recalled Budesonide Extended-Release Tablets, 9 mg on 12 Jan 2024. The recall is Class II and its status is Terminated. Recall number D-0276-2024.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: GS054862, Exp. Date 07/31/2025
Where was it sold?
Illinois only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Golden State Medical Supply
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS II | Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen | Golden State Medical Supply | Other | Nationwide |
Other Budesonide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 5mg/-dose ampules per, five recalledBudesonide | Cipla USA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets 9mg recalledBudesonide | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension 25mg/, For Inhalation Only recalledBudesonide | CIPLA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide and Formoterol Fumarate Dihydrate Inhalation recalledBudesonide And Formoterol Fumarate Dihydrate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |